Blaze Bioscience Announces Enrollment is Complete on its Pivotal Phase 2/3 Trial of tozuleristide and the CanvasTM Imaging System in Pediatric Central Nervous System Tumors

2022-11-02

SEATTLE--(BUSINESS WIRE)-- Blaze Bioscience Inc. the Tumor Paint Company® (Blaze), a biotechnology company dedicated to improving the lives of patients through development and commercialization of products for fluorescence guided cancer surgery, announced today that its pivotal Phase 2/3 study “A randomized, blinded study of fluorescence detection of pediatric primary central nervous system tumors in subjects receiving tozuleristide and imaged with the Canvas system” is now closed to enrollment, having achieved its trial accrual endpoints. The trial enrolled 123 subjects with various types of pediatric central nervous system (CNS) tumors. Subjects between the ages of one month and 30 years of age were enrolled and received tozuleristide prior to their planned tumor resection. A total of 9 clinical sites across the United States participated in the trial coordinated through the Pacific Pediatric Neuro-Oncology Consortium (PNOC). Gateway for Cancer Research provided support for patient and other costs and the Norcliffe Foundation provided Seattle Children’s Hospital (SCH) with a grant which allowed the inclusion of the Canvas imaging system at all sites in the study. The study was headed by Sarah Leary, M.D., neuro-oncologist at SCH and clinical investigator at the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute. “We are pleased to announce that enrollment is complete on this important trial. Pediatric brain tumors are still the leading cause of cancer-related mortality in children and teens. Improving surgical resection of brain tumors has been shown to be the single most important factor in improving survival and quality of life in brain tumor patients,” says Dr. Leary. “We are extremely grateful to the patients and their families who participated in this trial.” “Providing more options to patients and their families who are affected by a pediatric brain tumor is the driving force behind our work at Blaze,” says Kristi Harrington, M.D., Ph.D., Blaze Senior Vice President of Clinical. “We are excited to move forward with full data analysis and we are hopeful that tozuleristide and the Canvas imaging system may one day be useful in supporting neurosurgeon’s decision-making during brain tumor resection.” About BLZ-100 (tozuleristide) BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint® platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared (NIR) range. In addition to a Phase 2/3 clinical trial in pediatric CNS tumors, BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated preliminary clinical proof of concept in brain, breast, and skin cancers. Additional potential applications include prostate, head and neck, lung, colorectal and other solid tumor cancers. About the Canvas Imaging System The Canvas imaging system is an investigational medical device designed to provide high sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas imaging system was developed and is manufactured by Teal Light Surgical, Inc., a wholly owned subsidiary of Blaze. The first Canvas imaging system under development is adapted for use with surgical microscopes. About Blaze Bioscience Blaze is a privately held biotechnology company dedicated to improving the lives of cancer patients. Blaze is working to develop Tumor Paint products and related therapeutics. Surgery is first-line therapy for most solid tumor cancers and Tumor Paint products have the potential to improve cancer surgery by providing real-time, high-resolution visualization of cancer cells throughout surgery. For additional information, please visit or contact Kristi Harrington at clinicaltrials@blazebioscience.com.

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